Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-28 @ 5:32 AM
Study NCT ID:
NCT06400602
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Coaching for Back Pain After Emergency Department Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility - study enrollment', 'timeFrame': 'Baseline', 'description': 'Percentage of eligible patients enrolled into study'}, {'measure': 'Feasibility - study retention', 'timeFrame': '3 and 6 months after ED discharge', 'description': 'Percentage of enrolled participants who complete assessments'}, {'measure': 'Feasibility - session attendance', 'timeFrame': '3 months after ED discharge', 'description': 'Median and range of sessions attended'}, {'measure': 'Feasibility - Feasibility of Intervention Measure (FIM)', 'timeFrame': '3 months after ED discharge', 'description': '4-item questionnaire assessing feasibility of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater feasibility.'}, {'measure': 'Acceptability - Acceptability of Intervention Measure (AIM)', 'timeFrame': '3 months after ED discharge', 'description': '4-item questionnaire assessing acceptability of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater acceptability.'}, {'measure': 'Acceptability - Intervention Appropriateness Measure (IAM)', 'timeFrame': '3 months after ED discharge', 'description': '4-item questionnaire assessing appropriateness of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater appropriateness.'}, {'measure': 'Perceptions of intervention', 'timeFrame': '3 months after ED discharge', 'description': 'Perceptions of intervention as assessed through an interview'}], 'secondaryOutcomes': [{'measure': 'Disability - Oswestry Disability Index', 'timeFrame': 'Baseline, 3 months after ED discharge, 6 months after ED discharge', 'description': '10-item questionnaire assessing back-related disability. Scores range from 0 to 100, with higher scores indicating higher disability.'}, {'measure': 'Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'Baseline, 3 months after ED discharge, 6 months after ED discharge', 'description': '4-item PROMIS questionnaire assessing physical function. Scores are reported as t-scores, with higher scores indicating higher physical function.'}, {'measure': 'Pain Interference - Patient-Reported Outcomes Measurement Information System', 'timeFrame': 'Baseline, 3 months after ED discharge, 6 months after ED discharge', 'description': '4-item PROMIS questionnaire assessing pain interference. Scores are reported as t-scores, with higher scores indicating higher pain interference.'}, {'measure': 'Pain Intensity - Patient-Reported Outcomes Measurement Information System', 'timeFrame': 'Baseline, 3 months after ED discharge, 6 months after ED discharge', 'description': 'Single item question assessing level of pain intensity. Scores range from 0 to 10, with higher scores indicating higher pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED).\n\nThe main questions this feasibility trial aims to answer are:\n\n* Is our health coaching intervention and randomized trial methodology feasible to conduct?\n* Is our health coaching intervention acceptable to participants and ED providers?\n\nParticipants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview.', 'detailedDescription': 'This study is a two-group randomized feasibility trial of usual ED care plus either remote health coaching or remote education in patients with acute exacerbation of chronic low back pain presenting to the ED. We hypothesize that our health coaching intervention and randomized trial methodology will be feasible and that our health coaching intervention will be acceptable to participants and ED providers.\n\nForty participants will be randomized (20 per group), with 36 (90%) retained in the trial up to 6 months follow-up. Eligible patients presenting to the ED with a chief complaint of acute exacerbation of chronic low back pain will be randomized. Patients will be enrolled during or shortly after their ED visit, asked to complete a baseline questionnaire, and then randomized. Randomized participants will receive 8 calls from either a health coach or education provider, and be asked to complete assessments at 3 and 6 months after ED discharge. Interviews will be conducted with randomized participants and 15 ED providers asking about their experience with the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chief complaint of musculoskeletal LBP\n2. Meets NIH-supported chronic LBP criterion (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months)\n3. Age 18 years of age or older\n4. English-speaking\n\nExclusion Criteria:\n\n1. Requires hospitalization for an acute medical condition or active comorbidity\n2. In the opinion of the investigator has a severe psychiatric or behavioral diagnosis or substance use disorder that would interfere with the ability to perform the intervention and complete follow-up\n3. Involved in litigation related to the LBP condition'}, 'identificationModule': {'nctId': 'NCT06400602', 'briefTitle': 'Health Coaching for Back Pain After Emergency Department Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model', 'orgStudyIdInfo': {'id': '231665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Usual ED Care plus Health Coaching', 'interventionNames': ['Behavioral: Usual ED Care plus Health Coaching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual ED Care plus Education', 'interventionNames': ['Behavioral: Usual ED Care plus Education']}], 'interventions': [{'name': 'Usual ED Care plus Health Coaching', 'type': 'BEHAVIORAL', 'description': 'Patients will participate in eight remotely-delivered sessions of health coaching after ED discharge. Patients will receive usual care during their ED visit.', 'armGroupLabels': ['Usual ED Care plus Health Coaching']}, {'name': 'Usual ED Care plus Education', 'type': 'BEHAVIORAL', 'description': 'Patients will participate in eight remotely-delivered sessions of education after ED discharge. Patients will receive usual care during their ED visit.', 'armGroupLabels': ['Usual ED Care plus Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Valley Healthcare System - Nashville VA Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Rogelio Coronado, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Kristin Archer, PhD, DPT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Sean Collins, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Rogelio Coronado', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}